Participate in Research
We are looking for people interested in participating in a clinical study:
“Home Bladder Neuromodulation in Chronic Spinal Cord Injury”
Most people living with chronic spinal cord injury (SCI) have bladder dysfunction affecting their quality of life. Recently, our reviews of SCI research have found that the use of electrotherapy using skin electrodes can improve bowel and bladder function. Further, it can be used as an additional treatment of hand function, pain, and spasticity without any adverse effects.
Transcutaneous Electrical Nerve Stimulation (TENS) is non-invasive electrotherapy used over 30 years for clinical practices as an effective pain relief solution by sending electrical pulses through skin electrodes. TENS therapy is safe, inexpensive, and easy to use by self-administration without prescription. We are using FDA-approved TENS devices with a new approach at home to help chronic SCI people improving urinary function as the first pilot study in New Zealand.
Currently, we are conducting a clinical study that aims to evaluate whether TENS is feasible and safe to be performed at home and whether it improves urinary function and quality of life after the 4-week study. This study uses remote technologies to keep you safe during the COVID-19 restrictions.
You are invited to take part in this study if you:
- 18-75 years old
- Have had a spinal cord injury (at T12 level or above) for more than 1 year
- Live in the North or South Island
- Have bladder problems and use clean intermittent catheterisation
You will receive a new FDA-approved TENS device for daily self-administer electrotherapy (15 minutes/day) and collect data at your home for 4 weeks whilst continuing usual care. You will be asked to complete questionnaires/surveys about your spinal cord injury and bladder function, as well as to provide feedback on the TENS treatment and any side effects. The COVID-19 pandemic restriction should not affect this study as we will be using a tele-trial model composed of a webpage, mobile app, video conference (over zoom), video tutorials, live demo/training, and postal/courier services to deliver TENS device to your address.
We believe that the TENS therapy is feasible and safe to use at your home and can improve bladder function (reducing urine leakage and increasing urine volume). The results will be translated into the National clinical trial that will provide further evidence of health benefits (reducing urinary complications and caregiver support), cost-effectiveness (savings time and cost of hospital visits), and long-term quality of life for people living with SCI. If successful, we will apply this knowledge of home-use TENS to conduct further clinical studies for pain, spasticity, and hand function treatments.
As a thank you for your time and effort, you will receive a $100 gift voucher (eGift Card or equivalent) by the end of the study.
This clinical study is approved by the Health and Disability Ethics Committee (21/STH/171) and registered with the Australia New Zealand Clinical Trials Registry (ACTRN12621000869875).
If you would like to participate, please click this link:
Watch 3 minute-VDO of how to participate.
Participant Information and Informed Consent. (Download)
How to use TENS device. (Download)
If you have any questions at any point, please feel free to contact Sam Paritt.
Email: email@example.com (cc: firstname.lastname@example.org)